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Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial

Por: George · S. · Humphreys · S. · Williams · T. · Gelbart · B. · Chavan · A. · Rasmussen · K. · Ganeshalingham · A. · Erickson · S. · Ganu · S. S. · Singhal · N. · Foster · K. · Gannon · B. · Gibbons · K. · Schlapbach · L. J. · Festa · M. · Dalziel · S. · Schibler · A. · on behalf of the Pa
Introduction

Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.

Methods and analysis

The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2

Ethics and dissemination

Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.

Trial registration number

ACTRN12617000147381.

Influence of social determinants of health on patients with advanced lung cancer: a prospective cohort study

Por: Takemura · T. · Kataoka · Y. · Okazaki · K. · Sakurai · A. · Imakita · T. · Ikegaki · S. · Matsumoto · H. · Saito · E. · Takata · H. · Kaku · S. · Wada · N. · Shinomiya · M. · Otoshi · T. · Shimada · M. · Nikaido · J. · Iki · R. · Hirano · K. · Hirai · T. · Endo · K. · Naganuma · T.
Introduction

Socioeconomic factors with an influence on human health are known as social determinants of health (SDH). There are some SDH studies in patients with lung cancer, but important exposures such as social isolation and loneliness have not been adequately investigated. This study will assess the influence of SDH, particularly social isolation and loneliness, on patients with advanced lung cancer in Japan.

Methods and analysis

The inclusion criteria for this prospective cohort study will be as follows: a diagnosis of advanced lung cancer; unsuitability for curative surgery; and willingness to participate. The primary outcome will be the initial choice of treatment and the secondary outcomes will be overall survival, changes in disease staging or performance status, route to diagnosis and place of death. The exposures will be social isolation, loneliness, employment, insurance type, education and dementia. The study enrolment period will be 1 year and the follow-up duration will be 2 years. The log-rank test will be used to compare overall survival between patients when grouped according to the study exposures and multivariate analysis will be performed using Cox proportional hazards regression. The X2 test will be used to compare the initial treatment, changes in disease stage and place of death, and logistic regression will be used for multivariate analysis of these factors. A p value

Ethics and dissemination

This study has been approved by the Institutional Review Board at Hyogo Prefectural Amagasaki General Medical Center (No 29-164). A manuscript summarising the outcome of this study will be submitted to a peer-reviewed journal and the data will be presented at conferences.

Trial registration number

UMIN000031810.

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